Data / Medical devices / South Korea / Hanchang Co., Ltd
Hanchang Co., Ltd: FDA-registered device maker in Bucheon-si Gyeonggi, South Korea, 1 510(k) clearance
Hanchang Co., Ltd is registered with the FDA (registration 3007955117) in Bucheon-si Gyeonggi, South Korea. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 29, 2018. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3007955117
- Address
- # Bucheon Techno-park, 345, Seokcheon-ro, Bucheon-si Gyeonggi, South Korea, 14501
- Owner or operator
- HANCHANG Co., Ltd (10057970)
- Roles
- Manufacturer
- First device listed
- June 19, 2018
- Registered through
- 2027
- Brand names listed
- SpineKure Kyphoplasty System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Arthroscope | HRX | 2 | Manufacturer | accessdata.fda.gov |
| Cement, Bone, Vertebroplasty | NDN | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 29, 2018 | K172871 | SpineKure Kyphoplasty System | NDN | Substantially Equivalent | Hanchang Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 29, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.